Trials / Terminated
TerminatedNCT04936061
Transnasal Cooling for Migraine
A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- CoolTech LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CoolStat active device | The CoolStat active device will administer a therapeutic flow of dry air into the nostril. |
| DEVICE | CoolStat sham device | The CoolStat sham device will administer a sham flow of ambient air into the nostril. |
Timeline
- Start date
- 2021-10-14
- Primary completion
- 2022-08-31
- Completion
- 2022-09-30
- First posted
- 2021-06-23
- Last updated
- 2023-09-29
- Results posted
- 2023-09-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04936061. Inclusion in this directory is not an endorsement.